Senior Quality Engineer

Get 360Pharma; Leiden; Vor Ort; EUR 65.000 - 95.000; Vollzeit

Zusammenfassung

Get 360Pharma in Leiden, The Netherlands, is seeking a Senior Quality Engineer to reinforce our Operations quality team. The role focuses on implementing quality objectives, handling nonconformances, and updating procedures to reflect regulatory changes.

You will lead risk mitigation, drive continuous improvement, perform GEMBA walks for GMP compliance, and mentor teammates while collaborating with cross-functional stakeholders in a fast-paced pharma environment.

Qualifikationen

• Dutch language level A2 and English level B2 required.
• Bachelor or HBO in relevant field with required years of experience.
• Proficient in MS Office and data analysis.
• High accuracy and quality-focused attitude.
• Analytical thinking and root-cause analysis ability.
• Ability to work independently and in a team.
• Experience leading change controls or quality investigations.

Aufgaben

• Implement Operations quality objectives and perform nonconformance investigations.
• Update documentation per regulatory requirements and audits.
• Ensure compliant documentation and timely quality records.
• Initiate risk mitigations and drive continuous quality improvement.
• Support escalation processes for safety, product quality, and regulatory risks.
• Coach junior staff on risk mitigations and continuous quality projects.
• Lead cross-functional Operations quality improvements with stakeholders.
• Perform GEMBA walks to ensure GMP compliance and drive improvements.
• Develop training on cGMP processes and act as SME on non-conformances and Change Controls.
• Analyze data on recurring non-conformances and recommend corrective actions.

Kenntnisse

Analytical Reasoning

Coaching

Customer Centricity

Data Savvy

Document Management

Analytical Thinking

Team Leadership

Ausbildung

University degree or HBO with 5 years

Tools

MS Office

Data Analysis

Jobbeschreibung

We are searching for the best talent, Senior Quality Engineer. This position can be based in Leiden, The Netherlands.

Key Responsibilities

• Implement Operations unit quality objectives, including performing nonconformance investigations and maintaining procedures.
• Update documentation based on new or revised regulatory requirements, internal investigations, and audits.
• Ensure compliant documentation and timely completion of quality records.
• Initiate and implement risk mitigations and continuous quality improvement.
• Support formal escalation processes to ensure visibility of risks related to safety, product quality, and regulatory compliance.
• Coach less experienced team members in implementing risk mitigations and continuous quality improvement projects for the Operations unit.
• Initiate, drive, and lead cross-functional Operations unit quality improvements with stakeholders.
• Perform and direct comprehensive GEMBA walks to ensure GMP compliance and drive continuous improvement initiatives.
• Support development of training programs for general cGMP processes and act as a Subject Matter Expert on non-conformances and Change Controls during inspections and audits.
• Conduct data analysis on recurring non-conformances and recommend corrective actions.

Qualifications

Education

• A relevant university degree or equivalent experience with 3 years of shown experience (or HBO with 5 years).
• Dutch language level A2 and English language level B2 are required.
• Intermediate proficiency in MS Office, routine proficiency in data analysis, and specialist proficiency in business applications.
• High degree of accuracy and a quality-focused attitude.
• Analytical thinking: ability to handle complexity, ask questions, use data, identify gaps and root causes, and develop creative solutions.
• Positive demeanor, proactivity, decisiveness, and organizational skills; ability to work independently and as part of a team.
• Experience leading team initiatives and ensuring effective collaboration within the team.
• Proven experience leading change controls or quality investigations.

Preferred Skills

• Analytical Reasoning, Coaching, Customer Centricity, Data Savvy, Document Management
• Quality-related competencies: Good Automated Manufacturing Practice (GAMP), Lean Supply Chain Management, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation
• STEM background and related competencies; Supervision and Technological savviness; Supply Planning